Advise clients on regulatory and compliance matters involving the US Food and Drug Administration (FDA) at all stages of the biotechnology product life cycle, including pre-market product development and clinical and pre-clinical testing, product submissions, regulation of marketing and labeling of products, compliance with good manufacturing practice requirements, agency inspections and recalls, and enforcement actions. I work regularly with pharmaceutical, medical device, and other biotechnology companies on contract matters with respect to clinical studies and manufacturing, among other areas. I also frequently advise on regulatory matters in connection with capital markets, financings, and M&A transactions involving FDA-regulated entities. **Portions of this profile may constitute attorney advertising. Any testimonial or endorsement on this profile does not constitute a guarantee, warranty, or prediction regarding the outcome of your legal matter. Prior results do not guarantee a similar outcome.